civil False Claims Act (31 U.S.C. § 3729 et seq.) and state equivalents, the Federal Healthcare Fraud law (18 U.S.C. § 1347), the criminal false claims and false statements statutes (e.g., 42 U.S.C. § 1320a-7b(a), 18 U.S.C. §§ 286, 287, 1347, 1349, and 1001), the Federal Healthcare Program Overpayment Statute (42 U.S.C. § 1320a-7k(d)), the Medicare Secondary Payor Statute (42 U.S.C. § 1395y(b)), the Eliminating Kickbacks in Recovery Act (18 U.S.C. § 220 et seq.), (c) TRICARE, CHAMPVA, (d) HIPAA and all applicable federal and state laws, regulations and requirements for the protection of privacy and security of personal and medical information and data breach notification, (e) Medicare, (f) Medicaid, (g) accreditation standards and requirements of all applicable state laws or regulatory bodies, (h) all laws, policies, procedures, requirements and regulations pursuant to which Healthcare Permits are issued, (i) the Federal Program Fraud Civil Remedies Act (31 U.S.C. §§ 3801-3812), (j) the Federal Civil Monetary Penalties Laws (42 U.S.C. § 1320a-7a and 1320a-7b), (k) the Exclusion Laws (42 U.S.C. § 1320a-7), (l) the FDCA and regulations promulgated by the FDA and HHS, (m) laws regulating the research, development, investigation, testing, ownership, import, export, production, manufacturing, use, disposal, processing, transportation, handling, storage, holding, packaging, licensing, ordering, prescribing, dispensing, labeling, promotion, distribution, marketing, advertising, offer for sale, sale, and introduction or delivery for introduction into interstate commerce of any product, service, operation or activity, including the FDCA, regulations promulgated by the FDA, the laws of the U.S. Federal Trade Commission, including the U.S. Federal Trade Commission health breach notification rule, the U.S. Customs and Border Protection, state boards of pharmacy and health, and similar foreign, federal, state, and local Governmental Authorities, and all similar applicable laws and orders in each jurisdiction where the Borrowers’ products are offered for sale or sold, (n) the Clinical Laboratory Improvement Amendments, (o) the Physician Payments Sunshine Act (42 U.S.C. § 1320a-7h), as amended; (p) any Laws imposed, promulgated or enforced by the U.S. Department of Health and Human Services; (q) the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act; (r) the Inflation Reduction Act and implementing regulations, (s) any amendments to the laws in (a) through (r) and the regulations that implement the laws in (a) through (r); and (t) any and all other comparable state, federal or foreign healthcare laws, regulations, manual provisions, policies and administrative guidance, where such policies and administrative guidance have the force and effect of law, each of (a) through (s) as may be amended from time to time.
“Healthcare Permits” means with respect to any Person, any permit, supplier or provider number, accreditation, approval, clearance, exemption, authorization, license, registration, listing, certificate, concession, grant, franchise, waiver, variance or permission from, and any other contractual obligations with, any Governmental Authority, in each case whether or not having the force of law and applicable to or binding upon such Person or any of its property or operations or to which such Person or any of its property or operations is subject, in each case required under Healthcare Laws applicable to the business of the Borrowers or any of their Subsidiaries or necessary in the offer for sale, sale, furnishing, distribution, import, export, prescribing, ordering, introduction into interstate commerce, delivery for introduction into interstate commerce or delivery of goods or services under Healthcare Laws applicable to the business of the Borrowers or any of their Subsidiaries.
“HHS” means the U.S. Department of Health and Human Services, including the HHS Office of Inspector General and the Centers for Medicare & Medicaid Services.
“HIPAA” has the meaning assigned to such term in Section 5.01.
“Indebtedness” of any Person means, without duplication, (a) all obligations of such Person for borrowed money or with respect to deposits or advances of any kind, (b) all obligations of such Person evidenced by bonds, debentures, notes or similar instruments, (c) all obligations of such Person upon which interest charges are customarily paid, (d) all obligations of such Person under conditional sale or other title retention agreements relating to property acquired by such Person, (e) all obligations of such Person in respect of the deferred purchase price of property or services (excluding (i) deferred compensation, trade
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